Quality Control Barbara Weberman MT(ASCP) Oakland County Health Division Laboratory Supervisor

Quality Control
Barbara Weberman MT(ASCP)
Oakland County Health Division
Laboratory Supervisor
Clinical Laboratory Improvement
Act of 1988 (CLIA ‘88)
Set Minimum Standards for Quality Control
(QC)
Placed tests into complexity categories
 High complexity
 Moderate complexity
 Waived
The Rapid HIV tests are considered waived
Quality Control

Process that tracks the ability of reagents,
instrumentation, and personnel to obtain
an accurate result
How many controls
How often
Minimum requirements for waived tests
are the manufacturer’s
recommendations in the package insert
How many, how often?


There should be at
least one control per
reportable result
Reportable results
include positive and
negative results



Follow manufacturer’s
recommendation
May vary per
institution
Variables can include
per shift, day, week,
month, lot number,
shipment, personnel
What is the goal of QC?




To detect
SIGNIFICANT errors
rapidly
Report out good
results in a timely
manner
Be cost effective and
simple to use
If there is an error,
identify the source of
the error
What is an error???
A wrong answer. A
significant error is
one that changes the
diagnosis
Wrong answers can
be caused by random
errors or by
systematic errors
Types of Errors
Random=Fluctuations
Temperature
Personnel
Systematic
Reagent problem
Device problem
Internal and External Controls


Internal controls are
built into the test
device, such as a
control line in a
pregnancy test
External controls
consist of samples of
a known value that
you test as if they
were a patient’s
sample
Rapid HIV Oraquick Advance QC





Internal control
External controls –HIV 1, HIV 2, Negative
Controls must be run and must perform as
expected before any patients results are
reported
Daily – temperature documentation
Frequency of external controls:



High volume sites once per day
Low volume sites once per week
Off site or mobile location once per day
Oraquick Quality Control
Additionally, controls must be run:

With each new lot number of test
devices

With each new operator before testing
any clients for the first time

With each new shipment of test kits
received

If there is any change in the conditions
of testing (new location, lighting,
temperature, etc)

If the temperature of the test storage
area has fallen outside of range (35 C80 C)

If the temperature of the testing area
has fallen outside of range (59-99 C)

Whenever two consecutive invalid test
results are obtained on the same client

If there is a QC failure, repeat the QC
In summary




Perform QC according to your written
procedure
The procedure should at a minimum
follow the manufacturer’s recommendation
Document, document, document
No test should be reported out unless the
QC for that test is complete and correct